To monitor for immunogenicity, or the appearance of anti-drug antibodies, we have implemented a reflexive testing approach that aligns with American Gastroenterology Association (AGA) guidelines. This approach first measures the biologic concentration within a patient’s specimen. Then, if necessary, an additional test is performed to assess the presence of antibodies to a specific drug that the patient has been receiving. The information from these tests helps healthcare providers determine if patients are experiencing a loss of response to a specific therapy.
Biologics management Test menu
Clinically significant antibodies to biologic therapies are found in patients with very low trough concentrations in their serum. Therefore, a reflexive approach, which performs testing only when it is clinically relevant, benefits patients and reduces costs for the ordering institution. When concentration results are below a specified level, testing for antibodies to the specific drug will be performed at an additional charge.
For newer therapies such as ustekinumab that do not yet have well-established therapeutic thresholds and optimal concentrations associated with good outcomes, we offer testing that performs both quantitation and antibody testing on all specimens. We also offer this approach for infliximab and adalimumab therapies.
The panel approach may be considered if there is a known justification for performing both quantitation and anti-drug antibody reactivity. We offer a comprehensive menu of biologic testing for providers to order the right test for the patient at the right time. Offering a reflex test in addition to the panel provides versatility for physicians responding to patients’ needs. Furthermore, the panel will assist with proactive monitoring, which plays a significant role in helping some patients, such as the pediatric population, to manage IBD early in the treatment course.
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